Valvular & structural heart diseaseRandomised controlled trial
Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years
- Randomised controlled trial
- 7-year follow-up
Authors' conclusion
Among low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery.
Study context
- Population
- Low-risk patients with severe, symptomatic ASrandomised 1:1
- Participants
- 1,000 patients
- Comparison
- Transfemoral transcatheter aortic-valve replacement (TAVR) vs surgery
- Primary endpoint
- First: nonhierarchical composite of death, stroke or rehospitalization (procedure, valve or HF); second: hierarchical composite of death, disabling stroke, nondisabling stroke and rehospitalization days (win ratio)
- Follow-up
- 7 years
Primary result
As reported in the abstract
First primary end point (death, stroke or rehospitalization); second primary end point (hierarchical, win ratio)
Difference
−2.6 percentage points
95% CI −9.0 to 3.7
By group
TAVR vs Surgery
difference −2.6 percentage points (95% CI −9.0 to 3.7)
- Win ratio, second primary end point
- 1.04 (95% CI 0.84 to 1.30)
Further findings
Components of first primary end point · 7 years · Kaplan-Meier estimates
Death
Stroke
Rehospitalization
Bioprosthetic valve failure
Aortic-valve gradient (echocardiography) · 7 years
Patient-reported outcomes
- Similar in the two groups
Original publication
Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. Published 27 October 2025. doi:10.1056/nejmoa2509766
Summarised from the published abstract; every number is checked against it